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Fujifilm Medical Systems U.S.A., Inc.

Aspire FCRm/CRmFujilm CR for Mammography

Quality Control Manual

8th Edition: May 2013


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CONTENTS

FOREWORD ................................................................................................................................. 5

Introduction to Measurements ............................................................................................. 6

S value ............................................................................................................................................ 7

Overview of Testing ................................................................................................................... 8

Section A Getting Started .................................................................................................. 90 Set-up & Baseline Images ........................................................................................................10

Section B Weekly (QC Technologist) ............................................................................151 CNR ..................................................................................................................................................16

2 Phantom Image* ........................................................................................................................203 Printer QC ......................................................................................................................................28

4 Monitor QC ...................................................................................................................................30

Section C Monthly (QC Technologist) ..........................................................................335 Visual Checklist* .........................................................................................................................34

Section D Quarterly (QC Technologist) ........................................................................376 Repeat Analysis* .........................................................................................................................38

Section E Semi-Annual (QC Technologist) .................................................................437 Compression* ..............................................................................................................................44

8 Imaging Plate (IP) Fog ..............................................................................................................47

Section F Annual (Medical Physicist) ...........................................................................499 Viewing and Viewing Conditions .........................................................................................50

10 Printer QC ......................................................................................................................................51

11 Monitor QC ...................................................................................................................................53

12 S Value Conrmation ................................................................................................................57

13 System Resolution .....................................................................................................................6114 CR Reader Scanner Performance ..........................................................................................64

15 Mammographic Unit Assembly Evaluation* ....................................................................67

16 Collimation Assessment* ........................................................................................................70

17 Automatic Exposure Control (AEC) System Performance Assessment ...................76

18 System Artifact Evaluation* ....................................................................................................82

19 Image Quality Evaluation* ......................................................................................................85

20 Dynamic Range ...........................................................................................................................91

21 Primary Erasure (Additive and Multiplicative Lag Effects)...........................................94

(*) Portions of this test were reprinted from the ACR Mammography Quality Control Manual.

American College of Radiology; 1999


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22 Inter-Plate Consistency ............................................................................................................97

23 kVp Accuracy and Reproducibility ....................................................................................100

24 Dose ................................................................................................................................................101

25 Beam Quality Assessment and Half-Value Layer Measurement ................................102

26 Radiation Output ....................................................................................................................103

Revision History ..................................................................................................................... 105


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FOREWORD

Quality assurance (QA) in mammography means the planned and organized actions designed to

provide condence that mammographic equipment and related components operated in a facility

will reliably and consistently produce diagnostic quality mammograms for the screening and

diagnosis of breast cancer with minimum dose to patients and staff.

This document, FCRm/CRm Quality Control for Mammography Operation Manual, describes how to

conrm and verify that the Fuji Computed Radiography System when used with an MQSA compliant

X-ray system for screen-lm is working in a consistent manner according to the specications for use as

part of a Full Field Digital Mammography (FFDM) system.

This document applies to the CR-IR 348CL (hereinafter referred to as CR Console) and the CR-IR

363AWS (hereinafter referred to as AWS-c).

Always follow all applicable laws and regulations for your jurisdiction. If anything in this

document is in conict with applicable laws or regulations, the applicable law or

regulation shall take precedence.

AcknowledgementWe would like to thank the American College of Radiology, Reston, Virginia for their permission to

include portions of the 1999 ACR Mammography Quality Control Manual in this document which

have been reprinted with permission of the American College of Radiology.

No other representation of that material is authorized without expressed, written permission from the

American College of Radiology.

1 No part or all of this manual may be reproduced in any form without prior permission.

2 The information contained in this manual may be subject to change without prior notice.

3 FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from

installation, relocation, remodeling, maintenance, and repair performance by other than dealers

specified by FUJIFILM Corporation.

4 FUJIFILM Corporation shall not be liable for malfunctions and damages of FUJIFILM Corporation

products due to products of other manufacturers not supplied by FUJIFILM Corporation.

5 FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from remodeling,

maintenance, and repair using repair parts other than those specified by FUJIFILM Corporation.

6 FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from

negligence of precautions and operating methods contained in this manual.

7 FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from use

under environment conditions outside the range of using conditions for this product such as

power supply, installation environment, etc. contained in this manual.

8 FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from natural

disasters such as fires, earthquakes, floods, lightning, etc.

Caution: Rx Only (Federal law restricts this device to sale by or on the order of a physician.)

Trademark

FCR is a trademark or a registered trademark of FUJIFILM Corporation.

Copyright 2006-2009 FUJIFILM Corporation. All rights reserved.

DISCLAIMERS


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Introduction to Measurements

To produce consistently high quality images, each part of the imaging chain must function within the

limits of performance given. Users must therefore be able to evaluate the status of the acquisition

system, including detector, the processing system and the display systems.

AssumptionMany tests in this manual are specic to the Fuji Computed Radiology (FCR) mammography system

and its related components. Some tests are designed to verify use of the FCR mammography

system in conjunction with an X-ray generator and imaging chain components. It is therefore

required that the X-ray generator and the collimator are performing and calibrated in accordance

with MQSA requirements for screen-lm systems. The display systems used for nal interpretation

(soft copy and/or hard copy) must be calibrated and performing in accordance with the

manufacturer's quality control program for mammography use.

Processing System SoftwareThe processing system is evaluated by the inspection and scoring of a test set of phantom images

that have been processed in the CR Console/AWS-c with the standard mammography processing

algorithms EDR (Exposure Data Recognizer), and MFP (Multi-Objective Frequency Processing).

Processing parameters should be xed as a baseline for QC tests, specically the American College of

Radiology (ACR) mammography accreditation program phantom (MAPP) or other appropriate phantom

(RMI 156 etc.) test.

Dedicated Imaging Plates (IPs) and CassettesSome of the tests described in this manual utilize both sizes of the IPs and cassettes that are designed

for the imaging of high resolution mammograms. The customer should reserve one of each size IP and

one of each size cassette for Quality Control testing only, and should clearly identify these items as

intended for QC only. These IPs should not be used for patient imaging; and only these reserved IPs, and

cassettes should be used for QC procedures unless otherwise directed in this manual.

Use only the cassette and IP type designated for use with your Reader Unit (RU for mammographic

imaging and QC testing.

Clearview RU: Cassette Type DM with HR-BD IP.

Aspire CRm RU: Cassette Type CH with HR-VI IP.

Perform the S value Conformation test prior to the remaining Acceptance and QC tests, using

only molybdenum (Mo) target and Mo filter at 25kVp.

If the mammography X-ray unit will not allow 20 mR exposure, you may use the lowest mR

exposure available greater than 20. Always use 25 kVp for this test. Do not use any additional

filtration. The use of another filter may cause an error.

Cautions:


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S value

FCRm/CRm associates an S value with each FCRm/CRm image. Usually the S value is displayed with

other data in the hard copy or soft copy display.

Technically, the S value is defined by the equation S = 4 10(4-Sk)

, which is derived from the Sk value

determined by the Exposure Data Recognizer (EDR).

The meaning of the S value differs from that of relative sensitivity or relative speed used with screen-

film systems. Nonetheless, the S value can be used as a guide that roughly represents relative

sensitivity.

Note however, that:

With all other factors constant, the S value changes with time as the photomultiplier tube in the

FCRm/CRm equipment ages requiring periodic calibration.

The S value varies if the positioning setup changes even if the X-ray exposure and tube voltage

remain unchanged. If the exposure voltage (kVp) changes, the histogram changes, varying the S value.

If the X-ray apparatus changes, the S value changes even if the same exposure conditions are

used.

If the FCRm/CRm exposure menu is changed, the EDR conditions change so S value comparisons

would be invalid.

Even when exactly the same conditions are employed, the S value changes if the time interval

between IP exposure and IP insertion changes. When the X-ray generator, tube voltage, patient,

menu, positioning setup, and elapsed time from exposure remain unchanged, the S value is a

relative measure of the X-ray dose and is inversely proportional to it. For example, the S value is

approximately doubled when the dose is reduced by half.


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Overview of Testing

FREQUENCY TEST DESCRIPTION RESPONSIBILITY

SECTION A : Getting Started Set-up & Baseline ImagesTechnologist and

Medical Physicist

SECTION B : Weekly

(and when problems are

suspected)

CNR Weekly CheckTechnologist

Phantom Image

Printer QC*Technologist

Monitor QC*

SECTION C : Monthly


suspected)

Visual Checklist Technologist

SECTION D : Quarterly


suspected)

Repeat Analysis Technologist

SECTION E : Semi-Annual


suspected)

CompressionTechnologist

Imaging Plate (IP) Fog

SECTION F : Annual


suspected)

Viewing and Viewing Conditions*

Medical Physicist

Annual Printer QC*

Annual Monitor QC*

S Value Conrmation

System Resolution

CR Reader Scanner Performance

Mammographic Unit Assembly Evaluation

Collimation Assessment

Automatic Exposure Control (AEC) System

Performance Assessment

System Artifact Evaluation

Image Quality Evaluation

Dynamic Range

Primary Erasure

Inter-Plate Consistency

kVp Accuracy and Reproducibility

Dose

Beam Quality Assessment and Half-Value

Layer Measurement

Radiation Output

(*) Follow the manufacturers approved QC program if available.


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ASectionA Getting Started


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Set-up & Baseline Images

This section will guide you through the initial set-up and use of this manual. The tests are

performed by conducting a quantitative and visual inspection of test images and the ACR

Mammography Accreditation Program Phantom (MAPP).

Use this QC manual in conjunction with the operation manual for the FCRm/CRm reader unit,

the CR Console/AWS-c, and the FCRm/CRm User Guide. In the FCRm/CRm User Guide, refer to

Chapter 3 Getting Started - Calibrating the AEC for FCRm/CRm.

BASELINE TESTS OF FCRm/CRm SYSTEM

Complete the installation of the X-ray room and Fujifilm Computed Radiography system before

beginning the QC testing. Perform the tests in the table below as the baseline (first measurement)

for each QC test. If you are unsure about the status of your equipment, then ask the Fujifilm imaging

specialist, service engineer, or your physicist. Verify who is responsible for which device: the X-ray

manufacturer for the X-ray unit, Fujifilm service personnel for the FCRm/CRm and relatedequipment.

FCRm BASELINE TESTS

Printer QC (Annual)

Monitor QC (Annual)

CNR Weekly Check*

Image Quality*

S Value Confirmation*

System Resolution*

CR Reader Scanner Performance*

AEC System Performance Assessment

Imaging Plate Fog

System Artifact Evaluation*

Dynamic Range*

Primary Erasure*

Inter-Plate Consistency

Dose

* Indicates tests to be preformed when adding or replacing an FCRm/CRm Reader Unit.

Upon successful completion of the FCRm/CRm Reader Unit baseline tests, satisfy any MQSA

obligations prior to clinical use.

STEP 1: SETTING BASELINE TEST CONDITIONS

When testing equipment, it is very important that the test conditions are reproducible and

consistent. This involves setting up a baseline log for the X-ray room, FCRm/CRm system

parameters, and viewing conditions. These must be recorded in the EXPOSURE & IMAGE PROCESSING

SET UP. Always start by using your most consistent X-ray room and equipment. Decide on the X-ray

room and record it in the EXPOSURE & IMAGE PROCESSING SET UP. Select an IP and cassette of each

size that are in good condition to be put aside for the QC tests. Label them as such and write this

information in the EXPOSURE & IMAGE PROCESSING SET UP. Now record the AEC sensor position,

settings, X-ray generator, target, filter, grid and Image processing parameters that are being used

clinically and that you will use for the ACR MAPP.

Ensure that the menus shown in the following table are available. If you cannot find the menus,

create the menus according to the table on the following page.


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FCRm QC Test Menus and Parameters

GP MFP PEM *

GA GT GC GS MRB MRT MRE MDB MDT MDE PRN PTE PTC PRE

CREATED FROM HR

SENSITIVITY

Physics, Sensitivity 1.0 A 1.2 0.00 B F 0 A A 0 A A A 0

Physics, Artifacts 1.0 A 1.2 0.00 B F 0 A A 0 A A A 0

CREATED FROM CONTRAST

Physics, Collimation 1.3 C 1.2 0.00 B R 0 A A 0 A A A 0

Physics, IP Fog 1.3 C 1.2 0.00 B R 0 A A 0 A A A 0

CREATED FROM AVE5C16

Physics, Dynamic Range 1.0 A 1.6 0 C R 0.0 A A 0.0 A A A 0.0

Before evaluating the Physics, Dynamic Range test image, set the L value to 4.0.

CREATED FROM AVE5CB08

Physics, ACR MAPP 1.4 T 0.6 - C P 1.3 E F 0.4 B J G 2.0

Notes for the Physics ACR MAPP menu:

1) Change these image processing parameters to those parameters used for typical clinical images at your facility, if

necessary.

2) Set the GS value in the BASE LINE TEST so that the background image brightness or film density is acceptable

* PEM is only used with the Clearview RU-based FCRm systems.

In order to set up a different image processing parameter, please change MPM code of the menu

created.

NOTE

Select a viewbox or diagnostic workstation designed for final interpretation of mammographic

images that is located in a low ambient light environment. Also, mask unexposed areas of the

image to reduce glare. Luminance and ambient light measurements are recommended in order

to check that viewing conditions are adequate. These are included as part of a yearly physics

QC tests. The use of a magnifying lens with 2x magnification or greater is recommended for

evaluating tests from film.

STEP 2: THE QC TESTS

Before starting, read through the tests that make-up the QC program. Ensure that you have

access to everything listed under Required Test Equipment before beginning each test. Therelevant test result forms are found at the end of each test section.

It is important that you prepare for the quarterly REPEAT ANALYSIS as soon as you begin using

this QC program. Although you will only be doing the test quarterly, you will need to start

collecting the reject images now.

The annual tests are intended for the medical physicist and are more involved than the other

tests. A dose meter and densitometer will be required. These must be calibrated and have a

calibration certificate. These tests may also be needed if a problem arises during the daily,

weekly, monthly and quarterly testing. For example, if artifacts appear on images, it is

recommended that you do the artifact evaluation test.

Test images should be stored for future reference as directed in the test procedure.


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STEP 3: TAKING THE FIRST ACR MAPP IMAGES

Prior to producing the first phantom image, confirm that the display (image printer and/or

diagnostic workstation) is in control. Confirm that the FCRm reader unit has successfully passed the

S Value Confirmation Test.

Using the baseline setup from Step 1, expose the ACR MAPP or other FDA approved phantom

following the procedure in Phantom Image test (Test 2, Section B) and produce a baseline

image. Repeat this twice so that you now have 3 images with the same level of quality. If

significant variation is seen between the 3 images, it is important that the system is checked before

continuing with the QC program. Consult with the Fujifilm applications specialist. Choose one of the

3 comparable ACR MAPP images to be used as a reference for future tests.

Also, in accordance with the procedures of the Image Quality Evaluation Test, score the phantom

image to determine how many fibers, speck groups and masses are visible. These scores will

form the baseline for the ACR MAPP image tests.

STEP 4: TESTING AND CORRECTIVE ACTION LOG

Once the baseline values have been recorded and ACR MAPP baseline images have been

acquired and logged, it is possible to begin the QC program. During routine QC testing, a result

may exceed the acceptable limits. When this occurs, repeat the test to confirm the results. If the

re-test still exceeds the acceptable limits record the occurrence on the MAINTENANCE &

CORRECTIVE ACTION LOG. Investigate and correct the problem as directed in the test

procedure.


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EXPOSURE & IMAGE PROCESSING SET UP

DATE:

Baseline Phantom Exposure Settings

Room X-ray Generator

Target

Cassette ID No. Filter

IP ID No. KVp

AEC Sensor Position mAs

AEC Density Setting Grid

Baseline Image Processing Parameters

Basic

GA

GTGC

GS

Multi-Frequency MFP

MRB MDBMRT MDT

MRE MDE

Pattern Enhancement PEM*

PRNPTE

PTC

PRE

* PEM is only used with the Clearview RU-based FCRm systems.

Refer to User Guide - Mammography for detailed information about Image Processing

Parameters.

NOTE


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ASectionA Getting Started BSectionB Weekly (QC Technologist) (and when problems are suspected)


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1 CNR Weekly Check QC Technologist

OBJECTIVE

To establish an operating level of Contrast to Noise Ratio (CNR) at a specific exposure and weeklyconfirm that the CNR remains consistent, within limits over time at the same exposure setting.

This procedure is designed to measure the performance of the exposure system

FCR mammography system is a digital imaging system. Image density is programmed to a

specic level when using the auto or semi auto modes such as those used in routine

mammographic projections. Unlike screen-lm systems, optical density is not directly related to

exposure. Density and contrast are controlled by image processing.

NOTE

FREQUENCY

This test must be performed at installation after relocating the image reader as in a mobile setting

before imaging patients. In routine use, perform at a frequency of no less than weekly.

REQUIRED TEST EQUIPMENT

A 4cm phantom made of acrylic (PMMA) of fully covering an 18x24cm field size.

A 0.2 mm Al CNR test object.

The 1824cm dedicated QC Mammography cassette and Imaging Plate.

CNR BASELINE WORKSHEET

Watch/Timer

PROCEDURE

1. Using the 18x24cm dedicated mammography QC cassette, erase an IP using the secondary

erasure mode on the reader. Place the loaded cassette in the cassette holder assembly.

Set a manual technique using the following factors: large focal spot, Mo/Mo 26 kVp and 125

mAs. If 125 mAs is not available on the X-ray generator, use the next highest mAs setting.

Note: Establish the baseline CNR value by performing this test five times and averaging the

five CNR values. As the positioning of the aluminum plate may have some effect on the

calculated CNR, remove and reposition the aluminum plate after each exposure toreflect this normal variation in the baseline. Record the CNR value from each exposure

on the CNR BASELINE WORKSHEET. Calculate the average CNR and 20% values

and record them as indicated on the CNR BASELINE WORKSHEET. Repeat this

process whenever a new baseline is required (see Precautions and Caveats).


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2. Place the 4cm thick acrylic phantom with a 0.2mm thick aluminum object on top. Make sure

that the aluminum object completely covers the area shown in the diagram below.

BG

Calculation Areas(20mm 20mm)

Acrylic Slabs

Chest Wall Side

Al

Aluminum Object

60mm

20mm

20mm

20mm

3. Bring the compression device into contact with the phantom.

4. Make an exposure using the technique factors described in Step 1.

5. Wait the predetermined interval time and process the IP using the Physics ACR MAPP menu.

To reduce the inuence of IP image fading characteristics on this test, it is important to control

the time interval between X-ray exposure and reading of the IP. It is important that the interval be

consistent whenever this test is performed. We recommend choosing an interval between 5 and

10 minutes, then using the same interval consistently.

NOTE

6. Calculate CNR using the QC calculation tool and record the value in the data form.

7. Perform the Weekly CNR Test on all mammographic exposure units at your facility that use this

CR Reader.

PRECAUTIONS AND CAVEATS

Always be sure to use the same IP and cassette for this test. Always use the same exposure

technique as established in Step 1. Always wait the same amount of time between exposure and

processing of the IP when performing this test. Always erase the IP before performing this test.

Each exposure unit will produce a unique CNR baseline value. Be sure to only compare weekly test

results against the baseline of the same exposure system.CNR baselines must be re-established after major service or replacement events. These include but

are not limited to:

X-ray tube replacement

Filter replacement

Replacement of the compression paddle

Change in the phantom used

Change of IP and/or cassette used (always use the same IP and cassette)

Change of grid or table surface

Change of X-ray generator calibration

Change of CR Reader calibration

Following any of these events, a new baseline must be set. Calculate the new CNR baseline from 5

times of measured tests as described above and establish a new baseline.


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PERFORMANCE AND CORRECTIVE ACTION

The CNR of the new (weekly) image must be within +/- 20% of the baseline image (CNR) established

for the same exposure room.

If the CNR of the new image exceeds these limits, repeat the test confirming that all technique

factors are correct. If the new test results in a passing score record the results of the new test on

the Phantom Control/CNR Chart. Failure of this test can be a problem with the X-ray exposure unit or

CR reader unit. If the CR reader unit is used with more than one mammography X-ray exposure unit,

continue to perform the Weekly CNR Test on all mammographic exposure units used with the CR reader

unit.

If one exposure system fails and other exposure system(s) pass, it is likely that the cause of failure is

related to a change in the X-ray exposure system. Retest the failed system.

If the system fails the second test, the problem must be identified and corrective action taken before

any further examinations are performed using that exposure system. Record the corrective actionson the Maintenance & Corrective Action Log of the Phantom Control/CNR Test Report.

Review the PRECAUTIONS AND CAVEATS section to help determine if the change in CNR is

related to a service event or replacement product change that requires a resetting of baseline CNR

values.

If all exposure rooms fail and there has been no service calls or change in equipment in the exposure

room, the problem may be related to the CR reader unit. If this test produces results that fall outside the

action limits as specified by the manufacturer, the source of the problem shall be identified and

corrective action shall be taken on the component(s) that caused the failure before any further

examinations are performed using the failed component(s). If the component(s) that caused the failure(e.g. exposure unit, CR reader unit, display device) is replaced by an alternative device and the

mammography system passes the re-test, image acquisition and interpretation may continue using

that combination of devices.


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CNR BASELINE TEST

DATE:

Phantom : 4cm X-ray generator Number :

0.2mm Al Cassette - IP Number :

26kVp 125mAs FCRm/CRm reader ID :

CNR 1 :

CNR 2:

CNR 3 :

CNR 4 :

CNR 5 :

AVE. CNR (BASELINE):

+/-20% : to

SIGNATURE:


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2 Phantom Image (Weekly) QC Technologist

OBJECTIVE

To assure that contrast, uniformity and image quality (due to the X-ray exposure system, CR reader unit,printer, and workstation) are maintained at optimum levels.

FREQUENCY

This test must be carried out initially at installation, after appropriate calibration of the equipment to

establish a baseline level. Subsequently, it must be carried out at least weekly, after service to any

equipment, (i.e. the X-ray generator, FCRm/CRm reader unit, image laser printer, and workstation) and

whenever changes in image quality are suspected.

With mobile mammographic equipment, the performance of the system must also be confirmed

after arriving at a new location and prior to imaging patients, in addition to the weekly test.


ACR MAPP

Acrylic 4mm 1cm diameter disc (for hardcopy QC only)

Designated cassette and imaging plate used for mammography

Densitometer (for hardcopy QC only)

Phantom Control/CNR Charts

HARD COPY PHANTOM CONTROL/CNR CHART

SOFT COPY PHANTOM CONTROL/CNR CHART

Watch/Timer

PROCEDURE

1. Using the designated mammography cassette, erase the IP using the secondary erasure mode

on the reader.

2. Place the cassette in the bucky tray.

3. Place the phantom on the cassette holder and position it so the edge of the phantom is fully

covering and aligned with the chest wall side of the image receptor. Center the phantom, left

to right.

4. The 4mm thick acrylic disc required to be placed on the phantom for hard copy QC may be

present during softcopy QC, but is not required for softcopy QC. For QC of softcopy used for

final interpretation, proceed to step 6.

5. For hardcopy QC, secure the acrylic disk to the top of the phantom within the image area but

position it so it will not obscure details in the phantom. A suitable location is between and

slightly below the first and second largest fibers. Once located, the disc may be permanently

attached to the phantom with super glue.

6. Bring the compression device into contact with the phantom.

7. Verify the location of the AEC detector. It should be in the same location used for previousphantom images and completely covered by the phantom.


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8. Make an exposure using the AEC technique factors (target, filter, kVp, grid, density control

setting, etc.) currently used clinically for a 4.2-cm compressed breast of 50/50 composition.

9. Optionally, you may plot the mAs on the control chart after making the exposure. Recall that

mAs will change significantly in the AEC mode if a different kVp, target, or filter is selected. This

step, plotting mAs, is optional and not required.

10. After exposure, ensure that a predetermined interval time between 5 and 10 minutes elapses

prior to the reading process. Process the IP using the "Physics, ACR MAPP" menu.

It is important to control the time interval between exposure and reading of the IP. To minimize

variability, it is recommended that an interval be chosen somewhere between 5 and 10 minutes

and that this same interval be used consistently.

NOTE

11. Record the AEC density control setting on the control chart.

12. For printed images as a final interpretation: Measure the following densities. The backgrounddensity should be measured at the geometric center of the phantom image. The measured OD

must not be less than 1.20.

The DD measurement is obtained by subtracting the density inside the acrylic disc from the

density directly adjacent to the disc, in the direction perpendicular to the anode-cathode axis.

For consistent results, these measurements must be made at the same location each time.

Plot the background optical density and the DD on the Hard Copy Phantom Control Chart.

For softcopy images as a final interpretation: Plot the S value from the phantom image

exposure on the S value range line on the SOFT COPY PHANTOM CONTROL/CNR CHART .

VIEWING CONDITIONS

Phantom images should be read under optimal viewing conditions. General lighting should be at a

low level and diffused. Viewboxes or workstations should be positioned to avoid light from windows,

other viewboxes, and other sources of bright light, either direct or reflected. Images should be

masked to eliminate extraneous light. Use a magnification of 2X or higher for scoring speck groups

as well as other test objects.

DATA ANALYSIS AND INTERPRETATION

1. When scoring the phantom image, each object is scored separately. Always count the number

of visible objects from the largest object of a given type (i.e., fiber, speck group or mass)

downward until a score of 0 or 0.5 is reached, then stop counting for that object type.

2. Count each fiber as one point if the full length of the fiber is visible and the location and

orientation of the fiber are correct.

Count a fiber as 0.5 if not all, but more than half, of the fiber is visible and its location and

orientation are correct. Add each full or partial fiber to the total score, from the largest down to

the smallest visible, until a score of 0 or 0.5 is reached.

3. After determining the last fiber to be counted, look at the overall background for artifacts.

If a fiber-like artifact appears anywhere in the wax insert area of the image, but not in an

appropriate location or orientation, deduct the artifactual fiber from the last real half or

whole fiber score if the artifactual fiber is equally or more apparent.

Deduct only from the last real fiber.

Record the final score after artifact deduction in the appropriate space on the chart.


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4. Use large fieldof-view magnification to assist in the visualization of specks. For hardcopy

images, use a 2X or higher magnifying glass. For softcopy images, use the workstations

electronic magnification function. Starting with the largest speck group, count each speck

group as one point if four or more of the six specks in the group are visible in the proper

locations. Count a speck group as 0.5 if two or three of the six specks in the group are visiblein the proper locations. Count a speck group as 0 if none or only one of the six specks in the

group is visible in the proper location.

Add each full or partial speck group to the total speck group score, from the largest down to

smallest visible group, until a score of 0 or 0.5 is reached.

5. After determining the last speck group to be counted, look at the overall background for

artifacts. If noise or speck-like artifacts are visible in the wrong locations within the area of the

wax insert, and are as apparent as the real specks, deduct them one for one from the

individual specks counted in the last whole or half speck group scored, and adjust the score of

the last group appropriately. Record the final score after artifact deduction in the appropriate

space on the chart.6. Count each mass as one point if the minus density object is visible in the correct location, and

the mass appears to be generally circular against the background (i.e., greater than of the

perimeter or circumference is visible). A mass is counted as 0.5 point if the minus density object

is visible in the correct location, but the mass does not have a generally circular appearance.

Add each full or partial mass to the total mass score, from the largest mass down and until a

score of 0 to 0.5 is reached.

Record the raw mass score before artifact deduction.

7. After determining the last mass to be counted, look at the overall background for artifacts.

If a mass-like artifact is seen in the wrong location within the area of the wax insert, deduct the

artifactual mass from only the last real whole or half mass scored if the artifactual mass isequally or more apparent. Record the final score after artifact deduction in the appropriate

space on the chart.

8. Using magnification, carefully examine the image for non-uniform areas, the presence of dirt or

dust artifacts, grid lines, processing artifacts, or any other artifacts and compare the image to

the original and previous images.

9. Notice any artifacts or grid lines on the image. Investigate the source of any artifacts or grid

lines and record the events on the Maintenance/Corrective Action Log of the Phantom Control

Chart. The medical physicist can provide assistance in identifying the source of the artifacts.

Mammography phantom images should always be viewed

By the same person, if possible

On a quality-controlled QA Workstation, Primary Interpretation Workstation, or Viewbox

Under the same viewing conditions as the Radiologist review stations

Using the same type of magnication used for reading mammograms

Soft copy images should be window and leveled to best demonstrate the objects of interest

NOTE


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This test measures the output from all components in the imaging chain. Changes in image quality

may be due to film, cassettes, IPs, X-ray generator, added filtration, printer, or workstation.

Consequently, other tests will be necessary to determine the component, or components, causingthe change. It is also necessary to check if settings for the image reading mode or image processing

parameters are changed. These factors will have a large influence on the results of this test.

When any image parameters are changed, it is recommended to perform the Phantom Exposure

test to re-determine the new baselines. Record the imaging parameters used for this test on the

Exposure and Image Processing Set Up located in this manual.

A weekly phantom image-evaluation is required for only the most commonly used cassette size (18

24 cm), however, it may be useful to also image the phantom periodically with a large (24 30

cm) cassette.

A phantom image should be produced and evaluated if clinical images suggest problems with eithersize formats. Typical examples of problems that are specific to the bucky size are grid lines, or

compression paddle artifacts.

Non-uniformity in the images can degrade the quality of clinical mammograms. To evaluate uniformity,

expose an Fuji IP Cassette on top of the cassette holder to compare image uniformity with and without

the grid.


The total number of simulated masses, speck groups, and fibers visible in the phantom image

should not decrease by more than one-half, assuming the same individual is viewing the images

under identical conditions.

If a change in the number of test objects is noted, then the present image should be compared to

the original image and the previous image to determine if the change is real or if the individual

viewing the image has changed his or her criteria.

At a minimum, the four largest bers, the three largest speck groups and the three largest masses

must be visible. If your baseline image exceeds the above minimum scores, the new image score

should not decrease by more than one half object point from the original baseline level, however

the score must not fall below the four largest bers, the three largest speck groups and the three

largest masses.

NOTE

If printed images are used for final interpretation: The optical density (OD) of the film shall be within

control limits of 0.20, from the established operating level.

The acrylic discs used for the measurement of the density difference (DD) may vary in thickness.

Consequently, the density difference is a relative, not absolute measurement and is to be used only

for quality control purposes. It is essential to use the same acrylic disc if comparisons are to be

made between different facilities.

The density difference (disc vs. adjacent density) shall not vary by more than 0.05 OD from the

established operating level. If a new operating level for background optical density is chosen, then a

new operating level for density difference must be established. It is essential that all printers used to


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print mammography images at one facility produce similar film optical densities. It is not acceptable

to have one unit producing a film with an OD of 1.40 and another producing an OD of 1.80.

If softcopy images are used for final interpretation: The S value of the phantom image confirms the

exposure unit output and the FCRm/CRm reader sensitivity setting. The S value result must be plotted

on the SOFT COPY PHANTOM CONTROL/CNR CHART and must not vary by greater than 20%. If the

results exceed this control limit, make sure that the kVp and mAs are set properly and that the correct

menu is selected.

For both softcopy and hardcopy:

If the performance criteria for this test are not met, a second phantom image test should be

performed and evaluated. If the criteria are still not met, the reasons for this failure must be

investigated, corrective action taken, and the results documented before patients are examined with

this system. Any visual difference between the current phantom image and the saved original phantom

image should be investigated. Printer or FCRm/CRm reader unit artifacts, grid lines, or grid artifacts

should not be present since any of these may degrade clinical images.

The appearance of artifacts, grid lines, or grid artifacts; the number of masses, specks and fibers

visualized; or any other change in the visual appearance of the image should be reported

immediately to the medical physicist for further evaluation.

If this test produces results that fall outside the action limits as specified, the source of the problem

shall be identified and corrective action shall be taken on the component(s) that caused the failure

before any further examinations are performed using the failed component(s). If the component(s) that

caused the failure (e.g. exposure unit or CR reader unit) is replaced by an alternative device and the

mammography system passes the re-test, image acquisition and interpretation may continue using

that combination of devices.

If the failure has been determined to be of a diagnostic device used for mammographic image

interpretation (e.g. laser printer, physicians review station) the source of the problem shall be

identified and corrective action shall be taken before that device can be used for mammographic

image interpretation. Clinical imaging may be continued. If available, an alternative approved

diagnostic device may be used for mammographic image interpretation

Phantom images must be retained in the QC records for the last full year. (Softcopy images can be

locked on the QA and PACS workstation). The original baseline image must be retained until it is

necessary to establish a new baseline image.

NOTE


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HARD COPY PHANTOM CONTROL/CNR CHART

Room: Cassette ID No.: IP ID No.: Year:

Month:

Date:Initials:

AEC SETTING:

CNR Value:

CNR OK:

-15%

+0.05

-0.05

+0.20

+0.15

-0.15

-0.20

Fibers+0.5

Specks+0.5

- 0.5

- 0.5

- 0.5

Masses +0.5

+15%

Density Difference

Baseline

Background Density

No.Visible

mAs (optional)

+ 0.05

-0.05

+ 0.20

+ 0.15

-0.15

-0.20

+0 . 5

+0 . 5

- 0.5

- 0.5

- 0.5

+0 . 5

-15%

+15%

Baseline

Baseline


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SOFT COPY PHANTOM CONTROL/CNR CHART

Room: Cassette ID No.: IP ID No.: Year:

Month:

Date:Initials:

AEC SETTING:

CNR Value:

CNR OK:

-15%

Fibers+0.5

Specks+0.5

- 0.5

- 0.5

- 0.5

Masses+0.5

+15%

No.Visible

mAs (optional)

+0 .5

+0.5

- 0.5

- 0.5

- 0.5

+0.5

-15%

+ 15%

-20%

S Value

-20%

+20%+ 20%

Baseline

Baseline


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MAINTENANCE & CORRECTIVE ACTION LOG

DATE PROBLEM CORRECTIVE ACTION TAKEN SIGNATURE

Prepared by


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3 Printer QC (Weekly*) QC Technologist

OBJECTIVE

The printer used to produce films for final interpretation of mammography images must be clearedby FDA for that purpose. The objective of this test is to assure that the printer used for final

interpretation is performing according to the manufacturers specifications.

PRINTERS WITH MANUFACTURER-PROVIDED QC PROGRAM

*Follow the printer manufacturers QC program for test frequency, procedure, performance and

corrective action.

PRINTERS WITHOUT MANUFACTURER-PROVIDED QC PROGRAM

If the manufacturer does not provide a mammography printer QC program use the following.

FREQUENCY

This test must be performed initially before interpreting mammograms. *Perform weekly for dry print

imagers, daily before printing mammographic images for wet print imagers. Perform after any

service or maintenance on the mammographic printer system and whenever problems are

suspected.


QC pattern with a fixed digital value grayscale (e.g. TG18-QC or TG18-PQC). Contact yourprinter manufacturer for details.

Calibrated densitometer.

Report form, available from your printer manufacturer.

PROCEDURE

SET UP

1. Print the QC pattern.

2. Measure the image to identify the step which has an optical density closest to but not less than

1.20. Designate this step as the mid-density (MD) step.

3. Measure the image to identify the step with an optical density closest to but not less than 2.20

and the step that has an optical density closest to but not less than 0.45. Designate these

steps as the high-density (HD) and low-density (LD) steps. The difference between these two

steps is designated as the density difference (DD).

4. Measure the lightest (B+ F or unexposed) portion of the image. This is designated as B+F.

RECORDING THE QUALITY CONTROL STEPS

1. Print the QC pattern. Write the date and time on the film. Label the film with the printer ID ifthere is more than one printer.


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2. Measure the densities of the designated steps.

3. Plot the mid-density (MD), the density difference (DD) and the base-plus-fog (B+F) on the

control chart.

4. Determine if any of the data points exceed the control limits. If not, go to step 6. If so, exposeand process a second QC strip, double checking that the correct procedure is followed. If the

same results are obtained, proceed to step 5.

5. Circle any out-of-control data points and repeat the test. If any data point is still out of control,

correct the cause of the problem and repeat the test to confirm that the problem has been

corrected. Note the cause of the problem and the corrective action and plot the in-control

point.

6. Determine if there are any trends, i.e., three or more data points moving in one direction (either

upwards or downwards), in the MD, DD, or B+F. If trends are present but the data points have

not, as yet, exceeded the control limits, clinical mammogram images can be printed. It is

necessary to determine the cause of the trend and to monitor the processor closely to assurethat the control limits are not exceeded.

7. Retain the test film for at least the MQSA prescribed period, e.g., the last full month for daily

QC and the last 12 weeks for weekly QC.


* Perform this test using only the test patterns described above. Test patterns are specific to the

image matrix size and bit-depth. Using other patterns could yield erroneous results.

Film is produced in batches. Consequently, there may be slight variations in the characteristics of

the film between batches. In addition, film aging and storage conditions can also affect the

sensitometric characteristics of the film. Whenever a new emulsion of film is opened, it is necessary

to perform a laser density calibration with the new film. The operating level on the control chart

should be adjusted to the new levels for MD and DD.


If the MD and DD are within 0.15 of their respective operating levels, and the B+F is within + 0.03

of its operating level, the printer is in control, and no further action is required. If the MD and DD fall

outside the above control limits, corrective action must be performed and then confirmed by

performing the QC test again. The source of the problem must be corrected before any

mammographic images are printed. If this test produces results that fall outside the action limits as

specified above or by the manufacturer (whichever is applicable), the source of the problem shall be

identified and corrective action shall be taken before that device can be used for mammographic

image interpretation.

Clinical imaging may be continued. If available, an alternative FDA-approved for mammography

diagnostic display device may be used for mammographic image interpretation, provided it has

passed the applicable QC tests.


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4 Monitor QC (Weekly*) QC Technologist

OBJECTIVE

The objective of this test is to assure that monitors are performing according to the monitormanufacturers specifications. Both the monitors used for final interpretation of mammography

images (primary monitors), and monitors used for acquisition QC (secondary monitors) must be

tested. An additional requirement is that monitors used for final interpretation must have been

cleared by FDA for that purpose.

Commercial calibration software programs supporting the American Association of Physicists in

Medicine (AAPM) Assessment of Display Performance for Medical Imaging Systems (AAPM On-Line

Report No. 03, www.aapm.org) are available for use with this test.

MONITORS WITH MANUFACTURER-PROVIDED QC PROGRAM

*Follow the monitor manufacturers QC program for test frequency, procedure, performance and

corrective action.

MONITORS WITHOUT MANUFACTURER-PROVIDED QC PROGRAM

If the manufacturer does not provide a mammography monitor QC program, use the following.

FREQUENCY

This test must be performed initially before interpreting mammograms, weekly, after any service to

the monitor, and whenever problems are suspected.


AAPM TG18-QC, SMPTE RP133 or other patterns appropriate for the monitor to be tested

(contact your monitor or QC software manufacturer for details*).

A photometer to measure luminance of primary monitors.

Your own or the QC software manufacturer-provided report form. Note: The results of this and

other tests can be stored electronically as permitted by MQSA regulation or guidance

PROCEDURE

1. Display the QC pattern.

2. For primary monitors only: record the maximum and minimum luminance levels as directed by

your monitor or QC software manufacturer. The maximum luminance (Lmax) is typically

specified by the monitor manufacturer as the highest value that can be used without

compromising other performance characteristics, such as lifetime or resolution. The minimum

brightness (Lmin) is influenced by Lmax.

3. For both primary and secondary monitors: examine the image carefully to determine the

visibility of the following features:

a. Verify that the 5% signal level inset is visible in the larger 0% signal field.

b. Verify that the 95% signal inset is visible in the 100% signal field.


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c. Verify that each gray level step from 0% to 100% can be distinguished individually.

d. Verify that the alphanumeric characters in the image appear sharp and in focus.

e. Verify that the high-contrast bar images in the center and at the corners of the QC pattern

are distinguishable. The low-contrast patterns are not evaluated in this test.f. Record the results of the evaluations on your own form or one provided by the QC software

manufacturer.


*Perform this test using only the test patterns described above. Test patterns are specific to the

image matrix size and bit-depth. Using other patterns could yield erroneous results.

PERFORMANCE

If the following conditions are met, the Monitor QC Weekly check is acceptable:

For primary monitors only: the maximum luminance value (Lmax) is within the range specified by

the monitor manufacturer. For reference, the AAPM report recommends that once set, the

target level (Lmax) is maintained within 10% of the desired value.

For both primary and secondary monitors: the 5% inset in the 0% field and the 95%- inset in the

100% field shall be visible and the 0% to 100% gray level steps shall be distinguishable from the

adjacent steps.

The alphanumeric characters appear sharp and focused.

The high contrast line-pair patterns are distinguishable at the center and the corners of the

display in both the horizontal and vertical orientations.

The ability to distinguish the low-contrast line-pair patterns is not a requirement for this test.

Unless required by the monitor manufacturer, there is no action limit specication for Lmin in this

procedure

NOTE

CORRECTIVE ACTION

For primary monitors (used for final interpretation). If this test produces results that fall outside the

action limits as specified by the manufacturer, the source of the problem shall be identified and

corrective action shall be taken before that device can be used for mammographic image

interpretation. Clinical imaging may be continued. If available, an alternative approved diagnostic

display device may be used for mammographic image interpretation, provided it has passed the

applicable QC tests.

For secondary monitors (used for image acquisition QC). If this test produces results that fall outside

the action limits as specified by the manufacturer, the source of the problem shall be identified and

corrective action shall be taken on the monitor that failed before any further examinations are

performed using that monitor. If the monitor that failed is replaced by an alternative monitor that

passes the test, image acquisition may resume using the alternative monitor.


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MONITOR QC (WEEKLY) REPORT

Room:

Left or Single Monitor

Serial Number:

Right Monitor Serial

Number:

Date: Date:

Monitor LEFT RIGHT Monitor LEFT RIGHT

Luminance

(primary only)

Record values:

MIN / MAX MIN / MAXLuminance

(primary only)

Record values:

MIN / MAX MIN / MAX

Lmax Pass/Fail: PASS FAIL PASS FAIL Lmax Pass/Fail: PASS FAIL PASS FAIL

0%-5%

contrast:YES NO YES NO

0%-5%


95%-100%


95%-100%


Gray Steps: YES NO YES NO Gray Steps: YES NO YES NO

Alphanumeric: YES NO YES NO Alphanumeric: YES NO YES NO

Line-pair

images:YES NO YES NO

Line-pair


SIGNATURE SIGNATURE

Date: Date:

Monitor LEFT RIGHT Monitor LEFT RIGHT

Luminance

(primary only)

Record values:

MIN / MAX MIN / MAXLuminance

(primary only)

Record values:

MIN / MAX MIN / MAX

Lmax Pass/Fail: PASS FAIL PASS FAIL Lmax Pass/Fail: PASS FAIL PASS FAIL

0%-5%


0%-5%


95%-100%


95%-100%


Gray Steps: YES NO YES NO Gray Steps: YES NO YES NO

Alphanumeric: YES NO YES NO Alphanumeric: YES NO YES NO

Line-pair


Line-pair


SIGNATURE SIGNATURE


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ASectionA Getting Started CSectionC Monthly (QC Technologist) (and when problems are suspected)


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5 Visual Checklist (Monthly) QC Technologist

OBJECTIVE

To assure that mammographic X-ray system indicator lights, display, and mechanical locks anddetents are working properly and that the mechanical rigidity and stability of the equipment is

optimum.

FREQUENCY

This test should be carried out monthly or after any service or maintenance on the mammographic

X-ray system.


VISUAL CHECKLIST

PROCEDURE

1. Review all of the items listed on the visual checklist and indicate the status. Be sure to rotate

the C-arm the way you would for patient imaging.

2. Date and initial the checklist where indicated.


Some of the items on the visual checklist are operator convenience features. However, many of the

items are essential for patient safety and high quality diagnostic images. It may be necessary to add

additional items to the list that are specific to particular equipment or procedure.

These should be included on the checklist and in each evaluation.



shall be identified and corrective action shall be taken within thirty days of the test date. Clinical

imaging and mammographic image interpretation may be continued during this period.


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VISUAL CHECKLIST

Facility: Room#:

Unit: Year:

Pass =

Fail = F

Does not apply = NA

Month

Day

Initials

C-Arm

SID indicator or marks

Angulation Indicator

Locks (all)

Field Light

High tension cable/other cables

Smoothness of Motion

Cassette Holder

Cassette Lock (small and large)

Compression Device

Compression Scale

Amount of Compression:Automatic

Manual

Grid

Control Booth

Hand Switch Placement

Window

Panel switches/lights/meters

Technique charts

FCRm/CRmCondition of cassettes

Condition of IPs

OtherShields/Aprons/Gloves

Cones or collimatorsCleaning Solution


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ASectionA Getting Started DSectionD Quarterly (QC Technologist) (and when problems are suspected)


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6 Repeat Analysis (Quarterly) QC Technologist

OBJECTIVE

To determine the number and cause of repeated radiographs. Analysis of this data will help identifyways to improve efficiency and reduce costs, as well as reduce patient exposure.

FREQUENCY

Repeated images shall be evaluated quarterly.

In order for the repeat rates to be meaningful, a patient volume of at least 250 patients or 1,000

exposures is needed.


All rejected images (including data for repeated images that may have been placed in a patients

film jacket)

The total number of images produced during the test period

Means for sorting images (hardcopy or softcopy) during analysis

REPEAT RATE ANALYSIS data form

PROCEDURE

1. Start by removing all existing reject images (hardcopy) in the department taken prior to the

start of the analysis.

2. Take inventory of the image supply as a starting point to determine the total number of images

consumed during this test.

3. Start collecting all rejected images. Continue to collect for the length of time needed to

radiograph at least 250 consecutive patients.

4. Sort the rejected images into categories such as poor positioning, motion, compression, under

exposure, (these might be due to exposure or processing), artifacts (streaks, spots, etc.).

Good images (they appear to be acceptable mammograms when retrospectively evaluated

during the repeat analysis) may have also been repeated.

Some images may not have resulted in an additional exposure of the patient but may have also

been rejected. These include clear and QC images. Although it is appropriate to include wirelocalization images as part of the reject analysis, they should not be included in the repeat

analysis because they are taken as part of the wire localization process.

Rejected images are all images that are in the reject bin, including repeated images. Repeated images

are images that are retaken for inadequate quality. The reject bin does not include additional views

required to image selected tissue seen on the rst image. It also does not include images taken for the

purposes of including tissue that could not be positioned on the image receptor due to the size of the

breast. For facilities using softcopy for nal interpretation maintain a list of repeated images using the

REPEAT RATE ANALYSIS form included in this procedure.

NOTE


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5. Some facilities place all images (repeated and good images) in the patients film jacket so there

are no repeated images in the department. In this case, the reject/repeat analysis chart should

be completed as patient examinations are carried out.

6. Tabulate the counts from Steps 4 and 5, determining the total number of repeated images,

rejected images, and the total number of images exposed during the analysis period.

7. Determine the overall percentage of repeated images by dividing the total number of repeated

images by the total number of images exposed during the analysis period, then multiply by

100. Next, determine the overall percentage of rejected images by dividing the total number of

rejected images by the total number of images exposed during the analysis period, and

multiply by 100.

8. Determine the percentage of repeats in each reason for repeat category by dividing the

repeats in the category by the total number of repeated images and multiply by 100.


All images that are repeated should be included in the repeat analysis, not just those rejected by the

radiologist. Repeated images that have been placed in the patients jacket must be included in the

repeat analysis.

Including examinations on at least 250 patients (approximately 1000 images) allows for a minimum

number of rejected images so that reasonable statistics can be obtained for the analysis.

Collecting rejected images from a larger number of patients is encouraged because it will yield more

reliable data when evaluating causes for repeats. Facilities that do not examine 250 patients in a

quarter must still assess repeat images at least quarterly to determine the primary causes of

repeated images.There is a danger that technologists may alter their routine procedures or criteria for accepting

images if they know their repeated images will be analyzed. This should be avoided.

If the Auto or Semi EDR mode is selected, underexposed images will exhibit normal density,

however they may possess a grainy appearance and a higher than normal S value. Because of

this density adjustment, overexposed images will also appear normal in density but typically

produce a lower than normal S value. Consult with your medical physicist to optimize AEC or

manual exposures to ensure that optimal image quality is maintained at minimal dose.

NOTE


The overall repeat rate ideally should be approximately 2% or less, but a rate of 5% is probably

adequate if the radiologist and medical physicist agree that this is a reasonable level.

These rates should be based on a image volume of at least 250 patients to be meaningful.

A reason for repeat that is significantly higher than the others indicates an area for potential

improvement.

If the repeat rate exceeds the selected acceptance level of either 2% or 5%, or if the repeat or reject

rate changes from the previously measured rate by more than 2%, the change must be

investigated and corrective action taken if necessary.


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Any corrective action should be recorded on the bottom of the repeat analysis form.

The effectiveness of the corrective actions must be assessed by performing another repeat analysis

after the corrective actions have been implemented.

It is important to study films that are too dark or too light to determine if the underlying cause is the

exposure equipment, image printer, patient positioning, technique or sub-optimal setting of digital

image processing.


shall be identified and corrective action shall be taken within thirty days of the test date. Clinical

imaging and mammographic image interpretation may be continued during this period.


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REPEAT RATE ANALYSIS

DATE:

FACILITY: FROM: TO:

TOTAL NUMBER OF EXAMS:

TOTAL NUMBER OF FILMS: 1824 2430 OTHER TOTAL

REASON FOR REJECT

PROJECTION

CC MLO ML or LM AXILLARY OTHERTOTAL

REPEATS

% of

REPEATS

POSITIONING

PATIENT MOTION

COMPRESSION

ARTIFACTS

X-RAY EQUIP

MALFUNCTION

SOFTWARE

MALFUNCTION

AEC

MISPLACEMENTUNDER

EXPOSURE

OVER

EXPOSURE

INCORRECT

PATIENT ID

WASTE

SUB-TOTAL

GRAND TOTAL

REPEAT RATE = REPEATS

TOTAL FILMS INCLUDING REPEATSREPEAT RATE = %

REJECT RATE = ALL REJECT FILMS

TOTAL FILMS INCLUDING REPEATSREJECT RATE = %

COMMENTS FOR CORRECTIVE ACTION AND GOALS:

SIGNATURE:


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ASectionA Getting Started ESectionE Semi-Annual (QC Technologist) (and when problems are suspected)


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7 Compression (Semi-Annual) QC Technologist

OBJECTIVE

To assure that the mammographic system can provide adequate compression in the manual andpowered modes and that the equipment does not allow too much compression to be applied.

Adequate compression is essential for high quality mammography. Compression reduces the

thickness of tissue that must be penetrated by the radiation, thereby reducing scattered radiation

and increasing contrast, while reducing the breast thickness. Compression improves image

sharpness by reducing the breast thickness, thereby minimizing focal spot blurring of structures in

the image, and minimizing patient motion. In addition, compression makes the thickness of the

breast more uniform; resulting in more uniform film densities and a film which is easier to interpret.

FREQUENCY

This test should be carried out initially, then semi-annually, as part of a Mammography Equipment

Evaluation (MEE), and whenever reduced compression is suspected.


Analog Bathroom scale (the scale must be flat)

Several towels

COMPRESSION data form

PROCEDURE

1. Place a towel on the cassette holder (to protect the cassette holder), then place the analog

bathroom scale on the towel, with the dial or read-out positioned for easy reading.

Locate the center of the scale directly under the compression device.

2. Place several towels on top of the scale to prevent damage to the compression device.

3. Using the power drive, activate the compression device and allow operation until it stops

automatically.

4. Read and record the compression.

5. Release the compression device.

6. Using the manual drive, move the compression device downward until it stops.

7. Read and record the compression.

8. Release the compression device.


If the compression force exceeds 200 newtons (20.4 kilograms or 20 deca-newtons or 45 pounds)

in the initial power drive mode, immediately release the compression device and ask a qualified

service engineer to make appropriate adjustments.


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A compression force of at least 111 newtons (11.3kilograms or 25 pounds) shall be provided. The

maximum compression force for the initial power drive mode must be between 111 newtons

(11.3kilograms or 25 pounds) and 200 newtons (20.4kilograms or 45 pounds).

If these requirements are not met, a qualified service engineer must make the appropriate internal

adjustments and the system must be retested and pass the test before further exams are

performed.


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COMPRESSION

DATE:

SCALE I.D.:

MAMMOGRAPHIC UNIT AUTOMATIC COMPRESSION MANUAL COMPRESSION

lbs. lbs.

lbs. lbs.

lbs. lbs.

lbs. lbs.

ACCEPTANCE LIMITS

AUTOMATIC (25 - 45 lbs) PASS FAIL

CORRECTIVE ACTION NEEDED? YES NO

CORRECTIVE ACTION DESCRIPTION:

CORRECTIVE ACTION TAKEN? YES NO

CORRECTIVE DATE:

RESULTS OF NEW TEST: PASS FAIL

Comments:

SIGNATURE:


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8 Imaging Plate (IP) Fog QC Technologist

OBJECTIVE

To verify that IPs stored in the exposure room exhibit no evidence of unintentional exposure (fog).

Unintentional exposure of an IP may result in images with reduced contrast, increased graininess, or

exposure-related artifacts.

FREQUENCY

This test should be performed initially before any patients are imaged and then semi-annually or

whenever the location of the storage space for the IPs relative to the X-ray exposure unit or the

radiation shielding is changed. In mobile mammography, it is not necessary to perform this test after

each relocation if the storage space for the IPs relative to the X-ray exposure unit or the radiation

shielding is not changed.


One coin

Adhesive tape

One cassette with loaded IP

IP FOG data form

PROCEDURE

1. Select an FCRm/CRm cassette from the exposure room stock. Erase the IP using the secondary

erasure mode on the FCRm/CRm image reader.

2. Tape the coin to the front (exposure side) of the cassette and place the cassette in the

cassette storage area of the room with the coin facing the X-ray tube (i.e. the coin is between

the X-ray tube and the IP so that any X-ray exposure from the tube would cast a shadow on

the IP.)

3. Leave the cassette in place for a minimum of 3 clinical studies, or produce 10 exposures of the

accreditation phantom to simulate clinical use.

4. Remove the coin and process the IP in the FCRm/CRm reader unit using the Physics, IP Fog

menu.

5. Examine the image to see if the coin is visible and record the results on the IP Fog report form.


Reading the image using the wrong menu may give an erroneous result.


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A shadow of the coin should not be visible. If a shadow is visible, move the IPs to a more protected

location and perform the test again.

If this test produces results that fall outside these action limits, corrective action shall be taken

before further studies are performed. Image interpretation may be continued during this period.

IP FOG

DATE:

Reader Unit ID:

S value:

Storage Location:

# of Exposures:

ACCEPTANCE LIMITS

COIN VISUALIZED? PASS FAILCORRECTIVE ACTION NEEDED? YES NO

CORRECTIVE ACTION DESCRIPTION:

CORRECTIVE ACTION TAKEN? YES NO

CORRECTIVE DATE:

RESULTS OF NEW TEST: PASS FAIL

SIGNATURE:


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FSectionF Annual (Medical Physicist) (and when problems are suspected)Some or all of the annual tests may be required as part of a

Mammography Equipment Evaluation (MEE).


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9 Viewing and Viewing Conditions (Annual) MedicalPhysicist

This evaluation is specic to the viewbox and reading room conditions, for images for nal

interpretation.

NOTE

When interpreting hardcopy FCRm/CRm images, it is suggested that you view the printed FCRm/CRm

images under the same conditions as you would screen-film mammography images. Film masking

devices and hot lights must be available for use by the interpreting physician. The 1999 ACR

Mammography Quality Control Manual includes a section on viewbox luminance, room illuminance,

and masking, which may be used as a reference.

When interpreting softcopy images, follow the monitor manufacturers quality control procedures.

For monitors without a manufacturer-provided QC program, follow the monitor QC procedures

provided in this manual.


Softcopy final interpretation

If the Monitor QC (Annual) test performance criteria, other than interpretation environment

illumination, are not met, identify and correct the source of the problem before further final

interpretation of images displayed on those monitors.

Set the final interpretation environment illumination to the lower of a) that recommended in the

monitor manufacturers quality control program, if applicable, or b) 20 lux or lower. If the illuminationis greater than the value set as described above, the source of the problem must be identified and

corrective action taken before interpreting mammograms under these conditions.


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10 Printer QC (Annual*) Medical Physicist

OBJECTIVE

The printer used to produce films for final interpretation of mammography images must be clearedby FDA for that purpose. The objective of this test is to assure that the printer used for final

interpretation is performing according to the manufacturers specifications.

PRINTERS WITH MANUFACTURER-PROVIDED QC PROGRAM

*Follow the printer manufacturers QC program for test frequency, procedure, performance and

corrective action.

PRINTERS WITHOUT MANUFACTURER-PROVIDED QC PROGRAM

If the manufacturer does not provide a mammography printer QC program use the following.

FREQUENCY

This test must be performed initially upon installation before interpreting hard copy mammograms,

and after major repairs, such as those requiring a mammography equipment evaluation (MEE), and

then annually.


QC pattern with a fixed geometric pattern (e.g. TG18-QC or SMPTE RP133). Contact yourprinter manufacturer for details.

Metric Ruler

Report form, available from your printer manufacturer.

PROCEDURE

SET UP


2. Identify lines in each dimension that have a specified relationship (e.g. fixed length or distancebetween lines). Use these same lines for subsequent testing.

3. Measure the length of lines in the step above to establish a baseline. If the printer manufacturer

provides a test image with specified distances, compare your measurement to the provided

specification.

RECORDING THE OBSERVATIONS


2. Using the ruler, confirm that the lines are straight and undistorted.


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3. Measure the length of the lines.

4. Inspect the image for artifacts.

5. Inspect the image for banding and jagged edges of the straight lines.

6. Note any unusual mechanical noises or other observations.


*Perform this test using the QC pattern supplied (or recommended) by the printer manufacturer for

that printer model. If none is available, use a QC test pattern recommended by the AAPM or by one

of the approved MQSA accreditation bodies for this purpose. Using other patterns could yield

erroneous results. Unless otherwise specified by the printer manufacturer, the visual observations

should be made without magnification.


The tolerance for film printer artifacts should be similar to the tolerance for artifacts in screen-film

mammography. According to the 1999 American College of Radiology Mammography Quality

Control Manual, not all artifacts can be totally eliminated. It may be useful to use the concept of

ALARA (as low as reasonably achievable) when assessing artifacts. If they can be easily eliminated,

they should. If the artifact is difficult or expensive to eliminate and is subtle (not mimicking or

obscuring clinical information), it may be tolerable. The medical physicist should consult with the

interpreting physician as to whether the artifact is tolerable. Tolerances for artifacts should be lower

with new imaging equipment.

If any of the following problems exist:

The lines are bowed, bent or distorted

The lines exhibit jagged borders

The printer exhibits print or processing artifact that is judged intolerable

Measured distances vary by more than 1% from the reference standards

Artifacts are objectionable and can

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